title: Experience with a novel vaginal progesterone preparation in a donor oocyte program.
abstract: OBJECTIVE
  To compare the efficacy of a vaginal progesterone preparation with our standard IM preparation within a donor egg program.
  
  
  METHODS
  Prospective randomized trial.
  
  
  METHODS
  Donor egg program at a university assisted reproductive therapy program (Jones Institute for Women's Health).
  
  
  METHODS
  Couples accepted into the donor egg program because of either premature ovarian failure or evidence of diminished ovarian reserve.
  
  
  METHODS
  Women were randomized into either a group receiving IM progesterone replacement or a group receiving vaginal progesterone replacement. Both groups underwent Estraderm patch/progesterone treatment in a mock cycle leading to an endometrial biopsy on day 26 followed by a second cycle in which ET was performed. Subjects with residual ovarian function received a GnRH agonist. In the IM treatment group, 100 mg was administered from cycle days 15 to 27. In the vaginal treatment group, Crinone 8%, a polycarbophil-based gel preparation containing 90 mg of micronized progesterone, was administered twice daily from the evening of day 14.
  
  
  METHODS
  Endometrial histology, serum levels of progesterone (on days 13, 17, 20, 24, and 26), the occurrence of pregnancy, implantation rate, and pregnancy outcome.
  
  
  RESULTS
  Fifty-four women randomized into the vaginal progesterone treatment group and 18 women in the IM treatment group achieved ET. Mean serum progesterone levels were higher in the IM treatment group than in the Crinone group. Endometrial histology was "in phase" for all subjects in both groups. Clinical pregnancies were observed in 26 of 54 women and 5 of 18 women in the Crinone and IM progesterone groups, respectively. The ongoing pregnancy rate (PR) of 31% (17/54) and implantation rate of 23% in the subjects receiving Crinone was not statistically different from the IM progesterone group's ongoing PR of 22% (4/18) and implantation rate of 18%.
  
  
  CONCLUSIONS
  Vaginal progesterone replacement with the polycarbophil gel preparation was as effective as IM progesterone in producing clinical and ongoing pregnancies within our donor egg program in the dosages administered.
authors.affiliation: Jones Institute for Women's Health, Eastern Virginia Medical School, Norfolk 23507, USA.
authors.forename: W E
authors.initials: WE
authors.lastname: Gibbons
authors.forename: J P
authors.initials: JP
authors.lastname: Toner
authors.forename: P
authors.initials: P
authors.lastname: Hamacher
authors.forename: P
authors.initials: P
authors.lastname: Kolm
mesh_terms: D019326:17-alpha-Hydroxyprogesterone / Q000097:blood; D000282:Administration, Intravaginal; D000284:Administration, Oral; D001706:Biopsy; D010064:Embryo Implantation; D004717:Endometrium / Q000473:pathology; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D018587:Oocyte Donation; D010053:Ovary / Q000503:physiopathology; D011247:Pregnancy; D011256:Pregnancy Outcome; D018873:Pregnancy Rate; D016649:Primary Ovarian Insufficiency / Q000097:blood / Q000188:drug therapy / Q000503:physiopathology; D011374:Progesterone / Q000008:administration & dosage* / Q000097:blood / Q000627:therapeutic use; D011446:Prospective Studies
chemical_list: D011374:Progesterone; D019326:17-alpha-Hydroxyprogesterone